Fail-Safe Silicone Breast Implant Delivery Device

Abstract

A tapered sleeve is provided for implant delivery. An implant (e.g., a pre-filled silicone breast implant) is introduced into a large proximal end of the sleeve and extruded into a surgical pocket of minimal access incision size through a small-sized distal end of the device. Sized appropriately to the implant, the sleeve remains intact during implant run-through of the sleeve.

Description

CROSS-RELATED APPLICATION[0001]This application is a continuation-in-part of U.S. patent application Ser. No. 12 / 387,215, filed Apr. 29, 2009, which is fully incorporated herein by reference.BACKGROUND[0002]Silicone breast implants were re-approved in the United States in November, 2006, after having been withdrawn from the market. Implant recipients cite safety, scarring, and “natural” look and feel to be the top three indicators in selecting between saline- and silicone-filled implants for breast augmentation. Given that the more natural look and feel offered by silicone is a pre-requisite for many patients, silicone implants have already achieved nearly 50% market share following their return to the market.[0003]But because silicone implants are pre-filled (to alleviate leakage concerns) they have generally required larger access incisions than saline implants. Due to the possibility of visible scars associated with the larger incisions, some patients have remained apprehensive a...

AI Technical Summary

Benefits of technology

[0009]More specifically, since the size of silicone implants may vary in a range from about 150 cc to about 800 cc, the dimensions of the sleeve may vary. A proximal opening sized to fit any implant in this size range and a distal opening sized to fit the smallest implant may be desirable. The distal / tip opening then may be enlarged by trimming the sleeve to provide a larger opening. Indicia may be present on the exterior of the sleeve as a guide for cutting to the proper dimensions. Otherwise, a template or other means may be provided to assist in trimming.

[0025]The construction of the sleeve facilitates preparing it for use in the manner described by allowing compaction of the sleeve into a basin (i.e., a disposable bowl or other undersized container—such as the implant packaging itself—as typically available in an operating room). Specifically, the foldable (vs. merely flexible) nature of the fabric and non-interfering seam provide advantages. These features allow the device to be easily folded, crumpled or otherwise compacted to fit into such a container and at least substantially submerged in fluid without continued manual effort and / or compression under another object to push or hold it down. Moreover, such action (the compaction) is accomplished without damage to the sleeve. Ideally, no significant trace of the sleeve manipulation is evident when the device is put to use. That does not mean that no visual evidence of the manipulation remains. Rather, no structural damage has occurred.

Problems solved by technology

But because silicone implants are pre-filled (to alleviate leakage concerns) they have generally required larger access incisions than saline implants.

Due to the possibility of visible scars associated with the larger incisions, some patients have remained apprehensive about selecting silicone implants.

Hand manipulation can be time consuming even for a highly-skilled surgical practitioner.

The time spent has a direct bearing on the expense of the procedure.

The extent (and nature) of such manipulation also impacts the safety of the procedure.

Stated plainly, the poking and pushing required to manually insert a prefilled silicone implant can be quite rough.

Indeed, clinical studies have shown that the majority of silicone implant leaks / ruptures are attributable to sharp instrument damage and / or local stress forces exerted on the implant at the time of insertion.

However, little improvement has been made in the method of inserting the implants.

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